510(k) · Cleared
ClearedB-Capta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Livanova Deutschland, GmbH · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on Apr 1, 2021 as substantially equivalent to K001388 (Dideco, 2000) and 1 other predicate after a 241-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Apr 1, 2021
- Review
- 241 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001388 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK001388 Data Master Perfusion Monitoring SystemDideco · 2000
- 2 generations backK092463 Sorin B-CARE5 for the Stockert S5 SystemSorin Group Deutschland GmbH · 2009 · Recalled
- 1 generation backK103168 B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring…Sorin Group Deutschland GmbH · 2011
- This deviceK202154 B-CaptaLivanova Deutschland, GmbH · 2021
- Descendant · cites it directly · 0 of its ownK232291 Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001388 | Data Master Perfusion Monitoring System | Dideco | 2000 | — |
| −2 | K092463 | Sorin B-CARE5 for the Stockert S5 System | Sorin Group Deutschland GmbH | 2009 | 1 |
| −1 | K103168 | B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head) | Sorin Group Deutschland GmbH | 2011 | — |
| 0 (this device) | K202154 | B-Capta | Livanova Deutschland, GmbH | 2021 | — |
| +1 | K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRY device
- #1 K234065 CDI OneView Monitoring Systemscore 5.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001388 | Data Master Perfusion Monitoring SystemSummary page 5…0(k) Premarket Notification B-Capta III. PREDICATE DEVICE INFORMATION B-Capta is substantially equivalent in function and intended use to SORIN DATA MASTER (K001388) and the SORIN B-CARE 5 (K103168). IV. INDICATIONS FOR USE B-Capta is indicated for supplementary, in-line monitoring of… | 2000 |
| * | K103168 | B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head)Summary page 5…ta III. PREDICATE DEVICE INFORMATION B-Capta is substantially equivalent in function and intended use to SORIN DATA MASTER (K001388) and the SORIN B-CARE 5 (K103168). IV. INDICATIONS FOR USE B-Capta is indicated for supplementary, in-line monitoring of the extracorporeal arterial… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBM | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K232291 (Livanova Deutschland, GmbH, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K001388.
How does its category compare?
All DRY devicesDRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DRY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DRY
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRY
134in 2025
MAUDE reports naming product code DRY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 0 | — | 6 | 1,070 |
| 2011 | 2 | — | 14 | 2,268 |
| 2012 | 1 | — | 5 | 167 |
| 2013 | 0 | — | 0 | 157 |
| 2014 | 2 | — | 0 | 156 |
| 2015 | 0 | — | 1 | 231 |
| 2016 | 0 | — | 0 | 240 |
| 2017 | 1 | — | 0 | 61 |
| 2018 | 3 | 88 | 0 | 165 |
| 2019 | 0 | — | 0 | 63 |
| 2020 | 1 | — | 1 | 35 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 0 | — | 0 | 37 |
| 2023 | 0 | — | 0 | 41 |
| 2024 | 1 | — | 0 | 72 |
| 2025 | 0 | — | 0 | 134 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
B-Capta is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202154: B-Capta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202154
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026